Primary Objective: • Is there a minimal clinical difference (NRS >2) in pain levels between subjects receiving an arthroscopic debridement with a subacromial bio-absorbable Balloon and solely arthroscopic debridement in subjects with symptomatic…
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain measured through a Numeric Rating Scale (NRS).
Secondary outcome
-Time until the subjects receive a reversed shoulder prosthesis, if applicable
- Functional outcome measured through Oxford Shoulder Score and Total Constant
Score.
- Radiological outcome measured through Ultrascound and X-ray
-Complications
Background summary
Degenerative tears of the rotator cuff are common injuries seen in orthopaedic
subjects and can give rise to pain and disability. If conservative treatment
doesn*t give satisfactory decrease in pain, several surgical options for
massive cuff lesions are reported. Arthroscopic debridement as well as more
invasive surgery such as tendon transfers and prosthesis all give relative
satisfactory results. A novel minimal invasive treatment in subjects with
massive cuff lesion is the arthroscopic subacromial placement of the InSpace
balloon. This biodegradable Balloon has been placed more than 2000 times
worldwide up to now. In a small prospective study no implant based adverse
effects have been reported and most subjects report an improvement in pain
score and function (Senekovic et al. 311-16). We hypothesize that a significant
difference in pain levels at 12 months post surgery are found in subjects
receiving an arthroscopic debridement with a subacromial Balloon as compared to
subject who receive an arthroscopic debridement.
Study objective
Primary Objective:
• Is there a minimal clinical difference (NRS >2) in pain levels between
subjects receiving an arthroscopic debridement with a subacromial
bio-absorbable Balloon and solely arthroscopic debridement in subjects with
symptomatic irreparable cuff tears after 1 year.
Secondary Objective(s):
• Is the progress of pain and functional outcome different and clinically
relevant between the two study groups over the period of 1 year?
• What is the percentage of subject satisfaction after 1 year in the two study
groups.
• What is the percentage and type of complications after 1 year?
• To compare survival rates (with endpoint reversed shoulder prosthesis)
between both groups after 5 years.
*6. To compare the difference in developing osteoarthritis between the two
groups after 2 years.
Study design
Prospective, double blinded, randomized, controlled study.
Intervention
The patients will be randomized in a 1: 1 ratio in the two following sub-groups:
Group 1: Subjects will undergo a surgical intervention: arthroscopic
debridement and bicepstenotomie (when there was not already a rupture of the
biceps tendon preoperatively)
Group 2: participants will undergo a surgical intervention: arthroscopic
debridement and bicepstenotomie (when there was not already a rupture of the
biceps tendon preoperatively) with subacromial balloon placement.
Study burden and risks
Since an additional X-ray picture is taken, there is the risk of radiation
exposure. The total radiation exposure in this study was 0.1 mSv. By
comparison, the background radiation in the Netherlands is 2.5 mSv per year.
Furthermore, the patient will need to fill out additional questionnaires. This
is a time load.
Furthermore, the two procedures have a risk of complications. These are
described in the protocol and the patient is made aware of this by means of the
standard information leaflets.
Toneellaan 2
Zoetermeer 2725 NA
NL
Toneellaan 2
Zoetermeer 2725 NA
NL
Listed location countries
Age
Inclusion criteria
-Subject has an irreparable supra- and infraspinatus tendon tear confirmed by
ultrasound or MRI and is according to the Orthopaedic Surgeon a suitable
candidate for debridement.
-The symptoms of the subjects have been there for at least twelve months,
despite conservative treatment, including physiotherapy, subacromial
infiltration with corticosteroids or anti-inflammatory drugs.
-Subjects are older than 18 years.
Exclusion criteria
-Subject is not able to complete the daily questionnaires in Dutch.
-Subject, in the opinion of the investigator, is not able to understand this
investigation and is not willing and able to perform all study procedures and
co-operate with investigational procedures.
-Subject has glenohumeral osteo-arthrosis grade 3 and 4 (KELLGREN and LAWRENCE
494-502).
-Subject has a total subscalpularis tendon tear.
-Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in
the last 5 years) or has a psychological disorder that could affect their
ability to complete subject reported questionnaires or be compliant with
follow-up requirements
-Subject was diagnosed and is taking prescription medications to treat a
muscular disorder that limits mobility due to severe stiffness and pain such as
fibromyalgia or polymyalgia.
- Subject has an active elevation of less than 60 degrees (pseudoparalysis).
-Subject has participated in a clinical investigation with an investigational
product (drug or device) in the last three months.
- Subject is allergic to the Balloon material
-Subject has a medical condition with less than 3 years of life expectancy.
.-Subject has refused voluntary, written informed consent to participate in
this randomized controlled trial.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58522.098.16 |
| OMON | NL-OMON24952 |